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Preventing Medical
Device Recalls

DEV RAHEJA
Preventing Medical
Device Recalls
Preventing Medical
Device Recalls

DEV RAHEJA
CRC Press
Taylor & Francis Group
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Boca Raton, FL 33487-2742

© 2015 by Taylor & Francis Group, LLC

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Version Date: 20140611

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This book is dedicated to the managers and engineers who
do their best so nothing bad can happen to patients.
Contents

Preface...........................................................................xv
Acknowledgment........................................................ xvii
About the Author......................................................... xix
1 Introduction to Medical Device Requirements.........1
Introduction.......................................................................... 1
The Challenges..................................................................... 3
Sources of Errors.................................................................. 3
Understanding the Science of Safety................................... 7
Overview of FDA Quality System Regulation............. 7
Overview of Risk Management Standard ISO 14971.... 9
Overview of FDA Device Approval Process..............10
Overview of Regulatory Requirements for
Clinical Trials...............................................................11
Summary.............................................................................13
References...........................................................................14
2 Preventing Recalls during Specification Writing.... 17
Introduction.........................................................................17
Conduct Requirements Analysis to Identify Missing
Requirements......................................................................18
Specifications for Safety, Durability, and Reliability...........22
Specification for User Interface and Usability....................26
Specification for Maintainability.........................................26
Specification for Prognostics.............................................. 28
Specification for Safe Software...........................................29

vii
viii ◾ Contents

Negative Requirements Analysis for Worst-­Case

Scenarios.............................................................................29
Conducting PHA to Assess Risks.......................................30
Considerations for In Vitro Devices....................................30
Summary.............................................................................31
References...........................................................................31
3 Risk Assessment and Risk Management................33
Introduction.........................................................................33
Developing Risk Acceptance Criteria.................................34
Risk Analysis Using PHA....................................................35
Assessing the Risk...............................................................37
Mitigating Risks Using World-­Class Practices.....................38
Risk Evaluation....................................................................40
Managing Residual Risks....................................................40
Summary.............................................................................41
Reference.............................................................................41
4 Preventing Recalls during Early Design.................43
Introduction.........................................................................43
Functional FMEA on Design Concept to Prevent
Failures............................................................................... 44
Conducting a Component-­Level FMEA to Identify
Parameters Critical to Quality.............................................45
Conduct an FTA to Develop Robust Solutions for
Complex Problems..............................................................47
Strategy for Developing Solutions......................................51
Summary.............................................................................52
References...........................................................................52
5 Preventing Recalls during the Detail Design
Phase......................................................................53
Introduction.........................................................................53
Designing for Durability.....................................................54
Designing for Reliability.....................................................56
Designing for Inherent Safety.............................................58
Designing for Inherent Quality..........................................60
 Contents ◾ ix

Designing to Forgive User Errors.......................................60

Designing for Hazard-­Free Maintenance............................61
Designing for Packaging.....................................................62
Durability Testing................................................................63
Summary.............................................................................66
References...........................................................................66
6 Designing for Prognostics to Protect Patients........69
Introduction.........................................................................69
Preventing False Positives and False Negatives.................70
Designing for Alerts When the Device Is Not
Performing Accurately.........................................................72
Designing to Alert When a Device Is Near the Low
End of the Prognostic Distance..........................................73
Shutting Down the Device in a Safe State if the
Failure Cannot Be Avoided.................................................73
Progress in Prognostics Health Monitoring........................74
Summary.............................................................................75
References...........................................................................76
7 Preventing Recalls during Production Validation....77
Introduction........................................................................ 77
Understanding Key Design Features That Result in
Defect-­Free Production.......................................................78
Understanding the Theory of Profound Knowledge
for Superior Quality............................................................79
Conducting HAZOP Analysis to Identify Latent
Hazards in the Manufacturing Process..............................81
Using ISO 14971 HACCP Analysis to Identify Critical
Steps in a Process...............................................................81
Assuring Conformance to Key Design Features
without 100% Inspection or Testing...................................82
Auditing to Identify Unacceptable Variation before
Defects Are Produced.........................................................83
Taking Corrective and Preventive Actions Using the
FDA System........................................................................ 84
x ◾ Contents

Training Production Operators to Identify Incidents

That May Result in Device Defects................................... 86
Production Validation Testing............................................ 86
Summary............................................................................ 88
References.......................................................................... 88
8 Preventing Software Design Recalls.......................89
Introduction.........................................................................89
Software Requirements Analysis....................................... 90
Software FMEA...................................................................93
Software Interoperability Analysis.....................................94
Testability Analysis..............................................................94
Selecting Software Structure and Architecture................. 96
Precautions for Off-­the-­Shelf Software...............................97
Designing to Minimize User Interface Risks..................... 99
Common User Interface (UI) Issues.........................100
Common Reasons for Use Errors..............................100
Summary...........................................................................100
References......................................................................... 101
9 Preventing Supply Chain Quality Defects to
Avoid Recalls.........................................................103
Introduction.......................................................................103
Writing Good Supplier Specifications..............................104
The Art of Identifying the Features Critical to Quality....105
Assessing Variation in Supplier Quality...........................106
Supply Chain Control by Suppliers..................................106
Assuring Reliability in Performance.................................107
Summary...........................................................................107
Reference...........................................................................107
10 Preventing Recalls Using a Verification Process....109
Introduction.......................................................................109
Independent Verification during Specification Approval... 110
Independent Verification during Final Design Approval.... 111
Independent Verification during Pilot Production
Approval............................................................................ 112
 Contents ◾ xi

Independent Verification of Supplier Quality Assurance.... 113

Verifying Day-­to-­Day Control in Production................... 114
Summary........................................................................... 116
Reference........................................................................... 116
11 Preventing Recalls Using Design Validation
Process.................................................................. 117
Introduction....................................................................... 117
Design Validation Testing for Reliability.......................... 118
Design Validation Testing for Durability..........................120
Design Validation for Safety.............................................120
Using Field Validation to Identify New Risks..................122
Summary...........................................................................123
Reference...........................................................................123
12 Recall Planning to Maximize Efficiency in the
Event of a Recall...................................................125
Introduction.......................................................................125
Overview of the Plan........................................................126
Immediate Recall Coordination........................................127
Review of the Discovered Risks.......................................128
Review of Data Management............................................130
Verification of Activities for Effectiveness........................132
Closing the Recall..............................................................132
Summary...........................................................................133
References.........................................................................134
13 Role of Management in Preventing Recalls..........135
Introduction.......................................................................135
Management Policies........................................................136
Management Tasks for Preventing Recalls.......................137
Product Management Procedures.....................................139
Management Reviews.......................................................140
Monitoring Risk Management Processes.......................... 141
Using Good Paradigms for Efficiency..............................143
Summary........................................................................... 145
References......................................................................... 145
xii ◾ Contents

14 Innovation Methods Useful in

Preventing Recalls................................................ 147
Introduction....................................................................... 147
Stop Using Outdated Practices.........................................148
Use Heuristics................................................................... 151
Use the Profound Knowledge of the Quality and
Safety Gurus...................................................................... 153
Use Classic Innovation Methods....................................... 155
Summary........................................................................... 157
References......................................................................... 157
15 Proactive Role of Marketing in Preventing
Recalls................................................................... 159
Introduction....................................................................... 159
Don’t Repeat Failures of Yesterday in Devices of
Tomorrow..........................................................................160
Gather Intelligence on Customer Safety Needs during
Lead Generation................................................................ 161
Gather Intelligence on Safety and Quality Issues on
Device Search Engines...................................................... 161
Participate in Design Reviews to Be an Advocate for
Users.................................................................................. 162
Review New Device Specifications with Trusted
Customers..........................................................................165
Provide Intelligence in Risk Assessment to Ensure the
Public Health Benefits Outweigh the Risk....................... 165
Market Safety Features to Promote the Device and to
Get Feedback from Users.................................................166
Summary...........................................................................166
References.........................................................................166
Appendix A: Medical Device Safety from the
Hospital’s Point of View.............................................. 167
Protecting Patients from Hidden Dangers in Medical
Devices.............................................................................. 167
What Are the Dangers?.............................................168
 Contents ◾ xiii

How Can Hospitals Protect Patients from These

Dangers?..................................................................... 170
Use a Team Approach to Risk Reduction................. 171
References......................................................................... 171
Appendix B: The FDA Quality System Regulation........ 173
Code of Federal Regulations Title 21 (Food and
Drugs), Part 820................................................................ 173
Subpart A—General Provisions................................ 173
Sec. 820.1 Scope................................................ 173
Sec. 820.3 Definitions........................................ 176
Sec. 820.5 Quality System.................................. 179
Subpart B—Quality System Requirements............... 179
Sec. 820.20 Management Responsibility............ 179
Sec. 820.22 Quality Audit..................................181
Sec. 820.25 Personnel........................................181
Subpart C—Design Controls.....................................182
Sec. 820.30 Design Controls..............................182
Subpart D—Document Controls...............................185
Sec. 820.40 Document Controls........................185
Subpart E—Purchasing Controls...............................185
Sec. 820.50 Purchasing Controls........................185
Subpart F—Identification and Traceability...............186
Sec. 820.60 Identification...................................186
Sec. 820.65 Traceability......................................186
Subpart G—Production and Process Controls.........187
Sec. 820.70 Production and Process Controls....187
Sec. 820.72 Inspection, Measuring, and Test
Equipment..........................................................189
Sec. 820.75 Process Validation...........................190
Subpart H—Acceptance Activities............................ 191
Sec. 820.80 Receiving, In-­Process,
and Finished Device Acceptance...................... 191
Sec. 820.86 Acceptance Status........................... 192
Subpart I—Nonconforming Product......................... 193
Sec. 820.90 Nonconforming Product................. 193
xiv ◾ Contents

Subpart J—Corrective and Preventive Action..........194

Sec. 820.100 Corrective and Preventive
Action.................................................................194
Subpart K—Labeling and Packaging Control...........195
Sec. 820.120 Device Labeling............................195
Sec. 820.130 Device Packaging.........................195
Subpart L—Handling, Storage, Distribution, and
Installation.................................................................196
Sec. 820.140 Handling........................................196
Sec. 820.150 Storage...........................................196
Sec. 820.160 Distribution...................................196
Sec. 820.170 Installation.....................................197
Subpart M—Records.................................................197
Sec. 820.180 General Requirements..................197
Sec. 820.181 Device Master Record...................198
Sec. 820.184 Device History Record..................199
Sec. 820.186 Quality System Record.................199
Sec. 820.198 Complaint Files............................ 200
Subpart N—Servicing................................................202
Sec. 820.200 Servicing.......................................202
Subpart O—Statistical Techniques............................202
Sec. 820.250 Statistical Techniques....................202
Preface

A critical and sometimes overlooked aspect of preventing medi-

cal device recalls is the inability to implement systems thinking.
Systems thinking is not a panacea that can prevent every mis-
take, but it is the best-­known tool that helps us predict hidden
risks and see many robust solutions to eliminate risks. Unlike
the limited single-­focused cause-­and-­effect approach, systems
thinking is about the relationship of individual causes to system
causes, interdependencies of the knowledge of cross-­functional
teams, interdependencies of the knowledge of manufacturers
and device users, and understanding what you don’t know.
No individual has had more influence on quality manage-
ment than Dr. W. Edwards Deming. His Theory of Profound
Knowledge was the chief reason for the success of Japanese
businesses such as Toyota, Fuji, and Sony, and was the basis
of systems thinking. He taught them that a system is lot more
than the sum of its parts. Everyone doing their job right without
understanding the interactions and interdependencies among
subsystems and components is not enough. He preached
that management is accountable for 85% of problems—not
workers—because of a lack of systems thinking. His goal of
quality was to exceed customer needs through system improve-
ment. This book provides a structure for systems thinking to
most efficiently prevent device recalls.

xv
Acknowledgment

I am grateful to Dr. Peter Pronovost, senior vice president of

Patient Safety and medical director of the Center of Innovation
in Quality Patient Care at Johns Hopkins Hospital, for giving
me the inspiration to write this book. The idea started when
he and I wrote the article “Protecting Patients from Dangers
in Medical Devices.” That article is reprinted in Appendix A
of this book. Special thanks also to physicians and healthcare
professionals Dr. David Brown and Dr. Maria Escano (surgeon
and coauthor of several articles on patient safety). Thanks also
to Richard Ramirez, Avinash Konkani, Joseph Schnur, and
Gauri Raheja for making valuable suggestions.
I am especially thankful to Oriel STAT A MATRIX for
opportunities to teach medical device courses in their public
seminars for many years. Thanks also to my former employer,
GE Healthcare, for initiating my interest in public safety; to
Siemens Medical System for using my consulting services for
two years in Stockholm, Sweden; and to several universities
(University of California–­Los Angeles, George Washington
University, University of Wisconsin, University of Maryland,
and University of Alabama) for opportunities to teach short
courses on safety and reliability. Thanks to my family, espe-
cially Hema, for excellent support.

xvii
About the Author

Dev Raheja, MS, CSP, has been an international risk man-

agement and quality assurance consultant in the healthcare,
medical device, and aerospace industries for more than
twenty-­five years. He applies evidence-­based safety techniques
from a variety of industries to healthcare.
He is a trainer, and author of the books Safer Hospital Care,
Assurance Technologies: Principles and Practices, and Design
for Reliability. He shows clients how to create elegant solutions
using creativity and innovation. Being a true international con-
sultant, he has conducted training in several countries includ-
ing Sweden, Australia, Japan, Germany, the United Kingdom,

xix
xx ◾ About the Author

Singapore, Taiwan, South Africa, Finland, and Brazil. He

helped a major company in the midwestern United States
avoid going out of business and become a world leader by
eliminating safety mishaps.
Prior to becoming a consultant in 1982, he worked at GE
Healthcare as supervisor of quality assurance and manager
of manufacturing, and at Booz-­Allen & Hamilton as a risk
management consultant for the nuclear and mass transporta-
tion industry.
Raheja served as adjunct professor at the University of
Maryland for five years in its PhD program in reliability
engineering, and is currently an adjunct professor at Florida
Tech for its BBA degree in healthcare management. He is an
associate editor for healthcare safety for the Journal of System
Safety, and teaches webinars on medical device safety and reli-
ability. He has received several industry awards including the
Scientific Achievement Award and Educator-­of-­the Year Award
from the System Safety Society and the Austin Bonis Reliability
Education Award from the American Society for Quality.
He served as part of the first group of examiners for the
Malcolm Baldrige National Quality Award, and served for fif-
teen years on the board of directors of the Annual Reliability
and Maintainability Conference sponsored by ten engineer-
ing societies. Currently he is the member of the Institute of
Electrical and Electronics Engineers (IEEE), Association for the
Advancement of Medical Instrumentation (AAMI), the American
Society of Patient Safety Professionals, and the American College
of Healthcare Executives.
Raheja majored in human factors engineering as a part of
his master’s degree in industrial engineering, is a Certified
Safety Professional through the Board of Certified Safety
Professionals, and serves as the chairman of the Design for
Reliability Committee of the IEEE.
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